SPAARx heralds revised regulations to HIPAA HITECH Act

FLORHAM PARK, N.J. — A decision by the Department of Health and Human Services to resolve conflicts that arose when it issued regulations under a law that establishes privacy rules for health information technology has drawn applause from a specialty pharmacy organization.

The Specialty Pharmacy Association of America said that it received a "positive response" from HHS to concerns it expressed to the department about 2013 regulations under the HIPAA HITECH Act. According to SPAARx, a number of questions related to patient adherence and refill reminders under the regulations were left unresolved, resulting in conflict with healthcare practices for compliance and persistency programs developed by specialty pharmacies.

In response to lobbying by SPAARx and other industry groups, HHS provided revised guidance on remuneration for refill reminders and other similar communications. The previous guidelines allowed covered entities to be compensated for direct costs like labor, materials and supplies, while the new ones also include indirect costs like capital and overhead. In addition, business associates will be compensated based on the fair market value for patient adherence and refill reminder services.

"We are encouraged that the Department of Health and Human Services has responded to many of the clarifications that SPAARx and our specialty pharmacy members requested over the past several months," SPAARx CEO Kevin Alder said. "The clarifications they made are improvements to the rules governing the ability of specialty pharmacies to continue to advance the necessary patient-care to achieve positive patient health outcomes."

Forging stronger bonds of coordinated care between hospitals, community pharmacies

Community pharmacy’s long struggle to win professional recognition and a full seat at the health provider table is finally finding some traction as health systems, individual healthcare providers, health plans and plan payers begin to really connect the dots and build a workable framework for a more patient-centric, evidence-based and cost-effective system of care in the United States.

Momentum is growing for a higher level of pharmacy practice: one that broadens the role of the community pharmacist as an accessible, frontline health professional working in collaboration with a more integrated local healthcare network. Another example of the trend came last week, with the announcement by the American Hospital Association that it has endorsed the Walgreens WellTransitions coordinated care program.

As reported Sept. 19 by Drug Store News, the AHA recognized WellTransitions “as another tool for hospitals seeking to reduce readmissions and support overall community wellness,” according to Anthony Burke, president and CEO of AHA Solutions. Burke cited Walgreens’ “broad scope of services” and its “long-term commitment to supporting hospitals’ efforts to extend patient care further into their communities.”

That’s good news for all pharmacy chains and independents. There’s a general movement by community pharmacy to align its growing menu of pharmacist-delivered wellness services — including medication therapy management and other patient-care programs, medication adherence outreach efforts and the unique ability of pharmacists to deliver personalized patient care — more closely with local hospitals and health systems. And the focal point for many of those collaborative-care efforts is the process of discharging patients from the hospital back into the community.

That’s what WellTransitions was set up to do. Walgreens group VP Joel Wright says it involves company pharmacists working closely with the hospital discharge team “to improve the transition of patients to their homes by educating and encouraging them to take their medications as prescribed.”

If you’re a community pharmacist — or a hospital-based pharmacist who may be the final point of contact between the hospital and the patient prior to discharge — we’d like to hear from you. How seamless is the handoff between the hospital and the patient’s local community health system — including the local pharmacy network — in your area? Is there a true network of integrated care, a lot of room for improvement, or any contact at all with the community pharmacist once the patient leaves the hospital?

U.S. Type 2 diabetes market to more than double by 2019

NEW YORK — The global market for Type 2 diabetes will nearly double over the next six years, according to a new report.

GBI Research announced the release of a study Tuesday indicating that the market will grow from 2012’s $20.4 billion to $38.8 billion by 2019, at an annual growth rate of 10.2%. The United States’ market, meanwhile, will more than double, from $12.7 billion last year to $27.2 billion in 2019.

"The strong forecast for the Type 2 diabetes market is reliant upon the ability of late-stage pipeline drugs, such as gemigliptin, to reach expectations created by promising clinical trial results, and of newly marketed products, including [Takeda’s] Nesina and [Boehringer Ingelheim and Eli Lilly’s] Tradjenta, to capture significant share of the market," GBI analyst Dominic Trewartha said. Gemigliptin is the chemical name of Korea-based LG Life Sciences’ Zemiglo, currently approved in South Korea.

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Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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